Using Sugar Water to Relieve Pain in Infants

Pain Clinical Trial

Official title:

Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00213213
• Other study ID #: 1000002771
• Secondary ID: CIHR MCT-63143IS
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 11, 2010
• Start date: July 2003
• Est. completion date: July 2005

Study information

• Verified date: September 2005
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.

We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• healthy newborn infants =36 weeks gestation

• infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent)and infants born to mothers without diabetes

Exclusion Criteria:

• Admission to the neonatal intensive care unit

• plan to undergo circumcision during the study period

• major congenital or neurological anomalies

• clinical diagnosis of birth asphyxia or seizures

• receiving analgesics or sedatives

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Infant, Newborn
• Pain

Intervention

Drug:
• Sucrose

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
Secondary	(effectiveness):
Secondary	- Effectiveness of sucrose for repeated heel lances
Secondary	- Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture
Secondary	- Effectiveness of sucrose in decreasing pain response during Vitamin K injection
Secondary	- Determination of relationship between painful procedures and infant response during routine care procedures
Secondary	(safety):
Secondary	- Incidence of vomiting during administration of sucrose
Secondary	- Oxygen saturation during administration of sucrose
Secondary	- Serum Glucose concentrations in infants of diabetic mothers